Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.

Launched by MILITARY INSTITUTE OD MEDICINE NATIONAL RESEARCH INSTITUTE · May 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medication called Cerebrolysin to standard treatment can help patients recover better after experiencing an acute ischemic stroke. An acute ischemic stroke happens when a blood clot blocks blood flow to the brain, leading to potential brain damage. In this study, 50 patients who have had a stroke will receive Cerebrolysin within eight hours of the event, along with the usual treatment of mechanical thrombectomy (a procedure to remove the clot). Their progress will be compared to another group of patients who received only the standard treatment. The researchers are interested in seeing if those who receive Cerebrolysin experience better recovery in terms of daily activities and overall health.

To be eligible for this trial, participants should be between 18 and 80 years old, have specific symptoms of a stroke, and must have had a stroke that occurred within the last six hours. They should also have been independent in their daily activities before the stroke. If someone decides to participate, they will receive Cerebrolysin for 21 days and will also take part in a rehabilitation program to help regain their strength and abilities after the stroke. This trial aims to gather important information about how effective Cerebrolysin can be as part of stroke treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Clinical Inclusion Criteria:
• • 1. Age 18-80 years
• • 2. Signs and symptoms consistent with the diagnosis of an anterior circulation AIS
• • 3. Stroke onset to groin ≤6h (stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits).
• • 4. mRS ≤1 prior to qualifying stroke (functionally independent for all ADLs)
• • 5. moderate to severe stroke: NIHSS score of ≥5 with presence of any cortical signs (gaze, visual fields, language, or neglect)
• • 6. Initiation of treatment with Cerebrolysin ≤8h following stroke onset (Cerebrolysin group)
• • 7. Patient has signed the Informed Consent form (Cerebrolysin group)
• Neuroimaging Inclusion Criteria:
• • 1. CT ASPECTS ≥6 prior to MT
• • 2. ICA or MCA-M1 or -M2 occlusion (carotid occlusions can be cervical or intracranial; without tandem MCA lesions) by CTA
• • 3. Target mismatch profile on CTP (ischemic core volume \<70 ml, mismatch ratio ≥1.8 (ischemic penumbra at least 180% larger than the ischemic core volume) and mismatch volume ≥15 ml)
• • 4. Moderate-to-good collateral status on multiphase CTA (\>50% MCA territory)
• • 5. Effective reperfusion mTICI ≥2b following MT
• Exclusion Criteria:
• Clinical Exclusion Criteria:
• • 1. Other serious, advanced, or terminal illness or life expectancy ≤ 6 months
• • 2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations (e.g. Alzheimer's disease, vascular dementia, Parkinson's disease, demyelinating disease, encephalopathy of any cause,a history of significant alcohol or drugabuse)
• • 3. Pregnancy or lactation
• • 4. Known allergy to iodine that precludes an endovascular procedure
• • 5. Acute or chronic renal failure with calculated creatinine clearance \<30 ml/min/1.73m2 or unable to undergo a contrast brain perfusion scan withCT
• • 6. Inability to tolerate or comply with studyprocedures
• • 7. Any condition that would represent a contraindication for Cerebrolysin administration (e.g.allergy)
• Neuroimaging Exclusion Criteria:
• • 1. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion)
• • 2. Evidence of intracranial tumor (except small meningioma) acute intracranial hemorrhage, neoplasm, or arteriovenous malformation
• • 3. Significant mass effect with midline shift
• • 4. Treatment with another investigational drug within the last 30 days that may interfere with this study's medications
• • 5. Patients with nondiagnostic NCCT or CTP maps